Comparative Evaluation of Postoperative Pain and Success Rate After Pulpotomy in Mature Permanent Molars Using Biodentine Versus Mineral Trioxide Aggregate (MTA) as Capping Materials: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 70
- Primary Endpoint
- Postoperative pain after 6 hours postoperatively
Study Overview
Brief Summary
The aim of this study is to compare treatment outcomes of pulpotomy in mature permanent teeth using Biodentine versus MTA regarding postoperative pain and success rate.
Detailed Description
- Patients will be clinically and radiographically examined and their eligibility will be assessed.
- Eligible patients will be randomly assigned to one of 2 groups: experimental group (pulpotomy using Biodentine) and the control group (pulpotomy using MTA).
- After adminsrtation of local anesthesia, pulpotomy will be done under rubber dam isolation. The pulp tissue will be removed until the level of the orifices of the canals. After hemostasis is achieved, the capping material will be placed. In the experimental group, the capping material is Biodentine while in the control group, the capping material is MTA
- The cavities will be sealed with resin-modified glass ionomer. Then the teeth will be permanently restored with composite . A post-operative radiograph will be taken.
- The patients will be given a pain diary based on Numerical Rating Scale (NRS) and asked to rate their pain level at the specified times.
- The patients will be recalled after 6 and 12 months post-operatively.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
The study will be participant-blind where the participant will not know the intervention done.
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aging between 18-40 years old
- •Patients with symptomatic irreversible pulpitis.
- •Radiographically: Absence or slight widening in periodontal ligament space.
- •Systemically- healthy patients (ASA I or II).
- •Patients who agree to attend for recall appointments and provide written consent.
Exclusion Criteria
- •Severe marginal periodontitis.
- •Necrotic pulp, pulp polyp, tooth tender to percussion, clinical progression into periapical abscess, fistula.
- •Non-restorable teeth, teeth with internal/external root resorption or root canal calcification.
Arms & Interventions
Mineral Trioxide Aggregate (MTA)
Intervention: MTA Pulpotomy. (Procedure)
Biodentine
Intervention: Biodentine Pulpotomy (Procedure)
Outcomes
Primary Outcomes
Postoperative pain after 6 hours postoperatively
Time Frame: 6 hours postoperatively
Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10. 0 reading represents "no pain" 1- 3 readings represent "mild pain" 4- 6 readings represent "moderate pain" 7- 10 readings represent "severe pain"
Postoperative pain after 12 hours postoperatively
Time Frame: 12 hours postoperatively
Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10. 0 reading represents "no pain" 1- 3 readings represent "mild pain" 4- 6 readings represent "moderate pain" 7- 10 readings represent "severe pain"
Postoperative pain after 24 hours postoperatively
Time Frame: 24 hours postoperatively
Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10. 0 reading represents "no pain" 1- 3 readings represent "mild pain" 4- 6 readings represent "moderate pain" 7- 10 readings represent "severe pain"
Secondary Outcomes
- Overall (clinical and radiographic) success after 6 months postoperatively.(6 months postoperatively)
- Overall (clinical and radiographic) success after 12 months postoperatively.(12 months postoperatively)
Investigators
Youssef Andraws
Postgraduate Student, Department of Endodontics, Faculty of Dentistry, Cairo University
Cairo University